Pulse Oximetry, Skin Types
Conditions
Keywords
Skin types, Pulse oximetry
Brief summary
The primary objective is to gather missing information in order to form a well-founded recommendation on which is the preferred skin pigmentation measurement (PPM) methods in the context of pulse-oximetry.
Detailed description
Skin tone bias in pulse-oximetry (SpO2) needs to be addressed urgently. While skin pigmentation is a prime candidate for the root cause of skin tone bias in SpO2, more research is needed. F A solid comparison and recommendation requires evaluation of several additional aspects that affect accuracy, precision, and reproducibility of the PMMs. Briefly, these additional aspects that are evaluated in this study are listed below: * operator bias * impact of operator color blindness * probe pressure * probe aperture size * device stability * impact of blood on pigmentation measurement * feasibility of skin tone measurement on sides of fingers * intra-operator variability PMMs included in this study are: Subjective color matching methods by using: 1. Von Luschan color scale 2. Fitzpatrick color scale 3. Pantone color scale Objective probe-based measurements by using: 1. Konica Minolta CM700d (reflectance spectrometer) 2. Mx18 (erythema-melanin meter) 3. SPA99 (erythema-melanin meter) Measurements will be performed on 5 relatively light skinned, and 5 relatively dark skinned volunteers (N=10 in total\*). The study will be executed on the High-Tech Campus Eindhoven (Netherlands) and each participant will have 3 visits of approximately 1.5 to 2 hours/visit.
Interventions
OTHERObservational measurements of skin tone
Objective and subjective skin tone measurements will be performed.
Sponsors
Philips Electronics Nederland B.V. acting through Philips CTO organization
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Inclusion criteria
1. Adults (18-65 years) 2. Fluent in either English or Dutch 3. Participants who are willing and able to provide informed consent themselves. 4. People with Von Luschan scores \<18 ('light skin' group) or \> 25 ('dark skin' group).
Exclusion criteria
1. Skin conditions that could potentially interfere with the measurements: * piercings/ink/henna tattoos that cover the left forearm, hands, fingers or forehead * vascular or pigmentary or renal psoriasis * epidermal bullosum * other diseases that affect the skin (tone) of the body 2. COVID-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preferred skin PMM in the context of pulse-oximetry. | 10 months | The primary objective is to complement a previous skin pigmentation study executed by Philips to gather missing information in order to form a well-founded recommendation on which is the preferred skin PPM in the context of pulse-oximetry. |
Countries
Netherlands
Outcome results
None listed